TALLAHASSEE, Fla.—Attorney General Pam Bondi today announced that Florida has participated in the largest healthcare fraud settlement in U.S. history. Florida will receive more than $56 million as part of a $3 billion settlement with GlaxoSmithKline (GSK) that involved the federal government, Florida and various other states. The settlement resolves allegations that GSK engaged in a pattern of: unlawfully marketing certain drugs for uses that were not approved by the Food and Drug Administration (FDA); making false representations regarding the safety and efficacy of certain drugs; offering kickbacks to medical professionals; and underpaying rebates owed to government programs for various drugs paid for by Medicaid and other federally funded healthcare programs.

“My office has worked with others to reach the largest healthcare fraud settlement in United States history. I am proud to say that this agreement makes Florida whole for the deceptive practices that misled consumers and defrauded the Medicaid program out of money,” stated Attorney General Pam Bondi.

The settlement is based on four qui tam, or whistleblower, actions brought by private individuals pursuant to state and federal false claims acts, as well as investigations conducted by the federal government. A National Association of Medicaid Fraud Control Units team combined with several federal agencies to investigate the matter and conduct settlement negotiations with the defendants. Florida’s civil investigation was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is part of the Medicaid Fraud Control Unit.

Specifically, the government alleged that GSK engaged in the following activities:

·Marketing the depression drug Paxil for off-label uses, such as use by children and adolescents; · Marketing the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages; · Marketing the asthma drug Advair for off-label uses, including first-line use for asthma;· Marketing the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions; · Marketing the nausea drug Zofran for off-label uses, including pregnancy-related nausea; · Making false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;· Offering kickbacks, including entertainment, cash, travel, and meals, to healthcare professionals to induce them to promote and prescribe Paxil, Wellbutrin, Advair, Lamictan, Zofran, the migraine drug Imitrex, the irritable bowel syndrome drug Lotronex, the asthma drug Flovent, and the shingles and herpes drug Valtrex; and· Submitting incorrect pricing data for various drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.

As part of the settlement, GSK has also agreed to plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (“FDCA”) in connection with certain activities. The government alleges that GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs were misbranded, meaning they contained labels that were not in accordance with their FDA approvals, and that GSK failed to report certain clinical data regarding Avandia to the FDA.

The total Medicaid settlement amount for the State of Florida with the state and federal share combined is $56,682,425.59 plus interest. The federal share of this is $31,831,523.06, with the state share of Florida being $24,850,902.53. Florida’s state share of Medicaid damages is comprised of $11,252,063.09 in Medicaid restitution and $11,165,199.72 in additional recoveries.